Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Deroyal is conducting a voluntary recall of specific lots of insufflation tubing sets which are components found in the presource kits mentioned above. the reason for the recall is due to a materials incompatibility which could possibly result in occlusion at or near the filter housing. the occlusion could prevent the flow of gas through the device.